Leon Shargel, Isadore Kanfer
Published March 25, 2010
Reference - 288 Pages - 50 B/W Illustrations
ISBN 9780849377860 - CAT# DK7786
Series: Drugs and the Pharmaceutical Sciences
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Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives.
The contributors discuss measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, and transdermal drug delivery products, along with generic biologics and modified release parenteral drug products.
The book is essential reading for specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.
Introduction, Leon Shargel
Nonsystemically Absorbed Oral Drug Products, Marc Lefebvre
Topical Drug Products—Development, Manufacture and Regulatory Issues, Mary Beth G. Erstad and Candis Edwards
Assessment of Topical Dosage Forms Intended for Local or Regional Activity, Isadore Kanfer, Ralph Nii Okai Tettey-Amlalo, Wai Ling Au, and Betsy Hughes-Formella
Rectal Dosage Forms and Suppositories, K. Rosh Vora and Mohammed N. AliChisty
Nasal and Inhalation Drug Products, John Bell and Paul Flanders
Locally Acting Nasal and Inhalation Drug Products: Regulatory and Bioequivalence Perspective, Gur Jai Pal Singh
Transdermal Dosage Forms, Mario A. González and Gary W. Cleary
Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vivo Correlation (IVIVC) Principles, Siddhesh D. Patil and Diane J. Burgess
Biosimilar Drug Products—Manufacture and Quality, Suzanne M. Sensabaugh
"This is a must for pharmaceutical researchers who are involved in developing generic specialty products with proven bioequivalence."
—Doody's Book Review Service